Specialist upravljanja kakovosti - operacije (d/ž/m) / QA Operations Specialist (d/f/m)

Job Description Summary

Job Description

Več kot 40 različnih molekul in najvišji standardi kakovosti.
Pridružite se ekipi več kot 50 strokovnjakov s področja upravljanja kakovosti in skupaj z nami prispevajte k dostopnemu in kakovostnemu zdravljenju.

Proizvodna enota Aseptični izdelki Ljubljana zagotavlja napredne farmacevtske izdelke za globalni trg. Vse bolj se usmerjamo v biološko podobna zdravila, ki zahtevajo izjemno visoko raven kakovosti procesov, tehnologij in dokumentacije ter predvsem strokovnost, predanost in zavzetost zaposlenih.

Za področje upravljanja kakovosti procesov, izdelkov in opreme v proizvodni enoti Aseptičnih izdelkov iščemo Specialista upravljanja kakovosti.

Delovno mesto je namenjeno:

• sodelovanju pri zagotavljanju in upravljanju kakovosti redne proizvodnje aseptičnih izdelkov, ki vključuje različne proizvodne linije in farmacevtske oblike,
• sodelovanju pri projektih uvajanja novih izdelkov in novih farmacevtskih oblik bioloških zdravil,
• sodelovanju pri optimizaciji proizvodnih procesov in uvajanju nove proizvodne opreme,
• sodelovanju pri notranjih in zunanjih nadzorih ter inšpekcijah s področja kakovosti proizvodnih procesov, izdelkov in novih tehnologij.

Z zaposlitvijo v našem podjetju vam bomo med drugim omogočili:

• sistematično spoznavanje zakonitosti farmacevtske proizvodnje ter postopkov izdelave sterilnih izdelkov in nosnih pršil, vključno s postopki pakiranja za oskrbo trgov,
• spoznavanje postopkov vzpostavljanja razredov čistosti proizvodnih prostorov,
• sodelovanje pri uvajanju novih izdelkov, tehnologij in lansiranju izdelkov na nove trge,
• učenje in razvoj kompetenc s področja internega nadzora kakovosti ter spremljanje inšpekcijskih pregledov regulatornih organov.

Vaše ključne odgovornosti:

V našem multidisciplinarnem delovnem okolju  boste imeli dinamično in zanimivo delo z naslednjimi delovnimi nalogami in odgovornostmi:

• Sodelovali boste z ekspertnimi skupinami pri:
  - zagotavljanju standardov kakovosti novih tehnologij, procesov in izdelkov v fazi kliničnih testiranj  in za obstoječe procese redne proizvodnje   
  - izvedbi raziskav odstopov v proizvodnji
  - reševanju reklamacij naših izdelkov s trgov
  - zagotavljanju standardov kakovosti za strojno in sistemsko opremo
• Sodelovali boste pri prenosu novih izdelkov v redno proizvodnjo.
• Pregledovali in potrjevali boste tehnično – tehnološko in kvalifikacijsko dokumentacijo. 
• Skrbeli boste za izobraževanje o dobrih farmacevtskih praksah.
• Uvajali in zagotavljali boste standarde za obvladovanje sprememb ter izdelavo letnih pregledov kakovosti izdelkov, procesov, opreme in sistemov.
• Razvijali boste interne sisteme kakovosti v skladu s farmacevtsko zakonodajo, dobrimi farmacevtskimi praksami in Lekovimi in Sandozovimi  smernicami kakovosti.
• Opravljali boste interne nadzore kakovosti v proizvodnih procesih.

Vaš doprinos k delovnem mestu:

• Visokošolska stopnja izobrazbe ustrezne naravoslovne smeri (farmacija, kemija, kemijsko inženirstvo, kemijska tehnologija)
• Aktivno znanje angleškega jezika in slovenskega jezika.
• Delovne izkušnje s področja proizvodnje, razvoja in kakovosti.
• Želja po novih znanjih, osebnem razvoju, timskem delu in sodelovanju.

Kaj nudimo:

Lokacija dela: Ljubljana

Vrsta pogodbe: zaposlitev za določen čas enega leta, z možnostjo podaljšanja ter s šestmesečnim poskusnim obdobjem.

Predvideni tedenski delovni čas: 40

*Plačni razpon: 30.960–46.440 EUR bruto

*Plača v Sandozu temelji na nivoju delovnega mesta, kvalifikacijah, specifičnih veščinah in znanjih ter delovnih izkušnjah. Visoko usposobljeni kandidati so običajno umeščeni okoli mediane plačnega razpona, manj izkušeni na spodnji del razpona, kandidati z izrazito močnimi ali nišnimi kompetencami pa višje. Pri umeščanju v plačni razpon upoštevamo tudi notranjo uravnoteženost plač in zunanje tržne podatke.

Naš paket ugodnosti dodatno vključuje:

• Letni bonus (STI): odstotek letne plače
• Regres za letni dopust: leta 2025 je znašal 2.430,99 EUR (neto)
• Božičnica: leta 2025 je znašala 2.100 EUR (bruto)
• OurShare: Vsako leto bo zaposleni v družbi Lek d.d. upravičen do prejema delnic družbe Sandoz AG
• Prostovoljno dodatno pokojninsko zavarovanje: družba Lek d.d. v celoti krije mesečni prispevek za dodatno pokojninsko zavarovanje v višini 5,844 % vaše mesečne bruto plače
• Dodatek za izmensko delo (15 %); turnusno delo (20 %), nočno delo (70 %), delo ob nedeljah in praznikih (50 %), nadurno delo (30 %) – če to velja za zadevno delovno mesto
• Kolektivno življenjsko in nezgodno zavarovanje (kritje velja 24/7)
• Hibridno delovno okolje, ki omogoča fleksibilnost in možnost dela na daljavo. – če to velja za zadevno delovno mesto

Ste pripravljeni na naslednji korak v karieri?
Prijavo z življenjepisom v angleškem in slovenskem jeziku lahko oddate najpozneje do 09.05.2026

Zakaj Sandoz?

Sandoz je vodilni svetovni proizvajalec generičnih in podobnih bioloških zdravil – segmenta zdravstvene industrije, ki zagotavlja 80 % vseh zdravil na svetu po 30-odstotni ceni ter s tem vpliva na življenja več kot milijarde ljudi v več kot 100 državah. Čeprav smo ponosni na svoje dosežke, si prizadevamo narediti še več, da bi vsakdo imel dostop do temeljne človekove pravice – pravice do dobrega zdravja.

Z naložbami v nove razvojne zmogljivosti, proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza ter še večjemu številu ljudi omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil.

Naš zagon temelji na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci in sodelavke. V okolju, kjer so raznoliki načini razmišljanja dobrodošli in kjer se podpira osebna rast, imajo v zameno za uporabo svojih znanj možnost v celoti izkusiti delo v agilnem in povezovalnem okolju ter razvijati svojo uspešno kariero. 

Pridružite se nam in nam pomagajte povečati pravičnost in hitrost zdravstvenega varstva.

Prihodnost je v naših rokah.

Predani smo raznolikosti in vključenosti:

Zavzemamo se za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo. 

#Sandoz

_______________________________________________________________

More than 40 different molecules and the highest quality standards.
Join our team of more than 50 quality assurance professionals and work with us to support greater access to high‑quality, affordable treatments for patients worldwide.

Aseptics Ljubljana manufacturing unit provides advanced pharmaceutical products to patients around the world. We are increasingly focusing on biosimilars, which require exceptional quality of processes and procedures, and above all, high professionalism, dedication and commitment of all employees in the unit.

We are looking for a QA Operations Specialist to manage the quality of processes, products and equipment in the Aseptics Ljubljana manufacturing unit.

We’re opening this role to support:

• the rollout of new equipment for innovative pharmaceutical manufacturing;
• implementation of quality standards for the processes and equipment of regular pharmaceutical production for releasing the medicines to the markets.   

By joining our company, you will be able to:

• Become familiar with the principles of aseptic production and the procedures for manufacturing sterile products.
• Learn how to select and qualify equipment to ensure aseptic processes. 
• Get to know the procedures for establishing cleanliness zones in pharmaceutical production areas.

Your responsibilities include, but not limited to:

In our multidisciplinary working environment, you will have a dynamic and interesting career with the following roles and responsibilities:

• Collaborate with expert teams to ensure quality standards for new technologies, processes, and products during the clinical trial phase.
• Help maintain quality standards for equipment and system infrastructure.
• Participate in investigations of deviations related to manufacturing, equipment, and systems.
• Support the transfer of new products into commercial manufacturing.
• Review and approve technical, technological, and qualification documentation.
• Contribute to training and education in Good Pharmaceutical Practices (GxP).
• Help implement and maintain standards for change control and the preparation of annual product, process, equipment, and system quality reviews.
• Support the development of internal quality systems in line with pharmaceutical regulations, GxP, and Lek/Sandoz quality guidelines.

Essential Requirements:

• A university degree in a relevant science (pharmacy, chemistry, chemical engineering, chemical technology and other life sciences) or
• Active knowledge of English and Slovene.
• Work experience in production, development and quality.
• Desire for new skills, personal development, teamwork and cooperation.

What we offer:

Job location: Ljubljana

Contract type: temporary contract of 1 year with 6-month probation period

Expected weekly working hours: 40

*Pay range: €30,960 – €46,440 gross

*Salary at Sandoz is based on job level, qualifications, specific skills, and work experience. Fully proficient candidates are usually placed around the market median, less experienced candidates lower in the range, and those with strong or niche expertise higher. When determining placement within the range, we also consider internal pay equity and external market data.

Our compensation package additionally includes:

• Annual bonus (STI): percentage of annual salary

• Vacation allowance: in 2025 it was €2,430.99 net
• Christmas bonus: in 2025 it was €2,100 gross
• OurShare: every year, an employee of Lek d.d. will be entitled to receive shares of Sandoz AG
• Voluntary Additional Pension Scheme: The company fully covers the contribution for your supplementary pension plan, amounting to 5.844% of your gross salary
• Allowance for shift work (15%); rotational shifts (20%), night shift work (70%), Sunday/public holiday work (50%), overtime work (30%) – if applicable for position
• Collective life and accident insurance (24/7 coverage)
• A hybrid work environment offering flexibility and remote work possibilities – if applicable for position

Ready for your next career move?
You are kindly invited to submit your application in English and Slovene, including a CV, by May 5th, 2026.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have the ambition to do more so that everyone can benefit from the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions and partnerships, we have the opportunity to shape a sustainable future for Sandoz and to help even more people gain access to low-cost, high-quality medicines.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues who, in return for applying their skills, experience an agile and collegiate environment where diversity of thought is welcomed and where personal growth is supported! 

Join us in helping to make healthcare fairer and faster.

The future is ours to shape.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and to forming diverse teams that are representative of the patients and communities we serve. 

#Sandoz

Skills Desired

Global leader in generic and biosimilar medicines, operating as an independent company spun off from Novartis. Based in Basel.

sandoz.com